FDA Drug recall D-1543-2022
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis P…
- FDA Drug
- Class II
- terminated
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis P… by Novartis Pharmaceuticals, citing CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1543-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-09-16 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novartis Pharmaceuticals |
| Distribution | US |
Product
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Reason
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Identifiers
| ndc | 0078-0246-61 |
|---|---|
| ndc | 0078-0246-15 |
| ndc | 0078-0248-61 |
| ndc | 0078-0248-15 |
| ndc | 0078-0274-22 |
| code_info | Lot # APCD162, Exp. 01/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1543-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.